Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-31 @ 3:56 AM
Study NCT ID:
NCT00999869
Status:
UNKNOWN
Last Update Posted:
2012-08-07
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of terminal hair regrowth after intralesional botulinum toxin A injection', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Possible side effects of intralesional botulinum toxin a injection', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Newly diagnosed', 'Alopecia areata', 'Botulinum toxin A', 'Corticosteroid', 'Intralesional injection'], 'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '7791384', 'type': 'BACKGROUND', 'citation': 'Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.'}, {'pmid': '9238324', 'type': 'BACKGROUND', 'citation': 'McDonagh AJ, Messenger AG. The pathogenesis of alopecia areata. Dermatol Clin. 1996 Oct;14(4):661-70. doi: 10.1016/s0733-8635(05)70392-2.'}, {'pmid': '9520023', 'type': 'BACKGROUND', 'citation': 'Jackow C, Puffer N, Hordinsky M, Nelson J, Tarrand J, Duvic M. Alopecia areata and cytomegalovirus infection in twins: genes versus environment? J Am Acad Dermatol. 1998 Mar;38(3):418-25. doi: 10.1016/s0190-9622(98)70499-2.'}, {'pmid': '18425901', 'type': 'BACKGROUND', 'citation': 'Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.'}, {'pmid': '11030789', 'type': 'BACKGROUND', 'citation': 'Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.'}, {'pmid': '15692475', 'type': 'BACKGROUND', 'citation': 'Kar BR, Handa S, Dogra S, Kumar B. Placebo-controlled oral pulse prednisolone therapy in alopecia areata. J Am Acad Dermatol. 2005 Feb;52(2):287-90. doi: 10.1016/j.jaad.2004.10.873.'}, {'pmid': '6527956', 'type': 'BACKGROUND', 'citation': 'Lassus A, Eskelinen A, Johansson E. Treatment of alopecia areata with three different PUVA modalities. Photodermatol. 1984 Jun;1(3):141-4.'}, {'pmid': '3989026', 'type': 'BACKGROUND', 'citation': 'Mitchell AJ, Douglass MC. Topical photochemotherapy for alopecia areata. J Am Acad Dermatol. 1985 Apr;12(4):644-9. doi: 10.1016/s0190-9622(85)70088-6.'}, {'pmid': '3528241', 'type': 'BACKGROUND', 'citation': 'Tosti A, De Padova MP, Minghetti G, Veronesi S. Therapies versus placebo in the treatment of patchy alopecia areata. J Am Acad Dermatol. 1986 Aug;15(2 Pt 1):209-10. doi: 10.1016/s0190-9622(86)70158-8.'}, {'pmid': '2424249', 'type': 'BACKGROUND', 'citation': 'Vestey JP, Savin JA. A trial of 1% minoxidil used topically for severe alopecia areata. Acta Derm Venereol. 1986;66(2):179-80.'}, {'pmid': '3292159', 'type': 'BACKGROUND', 'citation': 'Fransway AF, Muller SA. 3 percent topical minoxidil compared with placebo for the treatment of chronic severe alopecia areata. Cutis. 1988 Jun;41(6):431-5.'}, {'pmid': '3549809', 'type': 'BACKGROUND', 'citation': 'Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.'}, {'pmid': '3314718', 'type': 'BACKGROUND', 'citation': 'Fiedler-Weiss VC, Buys CM. Evaluation of anthralin in the treatment of alopecia areata. Arch Dermatol. 1987 Nov;123(11):1491-3.'}, {'pmid': '2007667', 'type': 'BACKGROUND', 'citation': 'van der Steen PH, van Baar HM, Happle R, Boezeman JB, Perret CM. Prognostic factors in the treatment of alopecia areata with diphenylcyclopropenone. J Am Acad Dermatol. 1991 Feb;24(2 Pt 1):227-30. doi: 10.1016/0190-9622(91)70032-w.'}, {'pmid': '2138175', 'type': 'BACKGROUND', 'citation': 'Gupta AK, Ellis CN, Cooper KD, Nickoloff BJ, Ho VC, Chan LS, Hamilton TA, Tellner DC, Griffiths CE, Voorhees JJ. Oral cyclosporine for the treatment of alopecia areata. A clinical and immunohistochemical analysis. J Am Acad Dermatol. 1990 Feb;22(2 Pt 1):242-50. doi: 10.1016/0190-9622(90)70032-d.'}, {'pmid': '8996277', 'type': 'BACKGROUND', 'citation': 'Shapiro J, Lui H, Tron V, Ho V. Systemic cyclosporine and low-dose prednisone in the treatment of chronic severe alopecia areata: a clinical and immunopathologic evaluation. J Am Acad Dermatol. 1997 Jan;36(1):114-7. doi: 10.1016/s0190-9622(97)70342-6. No abstract available.'}, {'pmid': '18543595', 'type': 'BACKGROUND', 'citation': 'Bui K, Polisetty S, Gilchrist H, Jackson SM, Frederic J. Successful treatment of alopecia universalis with alefacept: a case report and review of the literature. Cutis. 2008 May;81(5):431-4.'}, {'pmid': '15313825', 'type': 'BACKGROUND', 'citation': 'Ettefagh L, Nedorost S, Mirmirani P. Alopecia areata in a patient using infliximab: new insights into the role of tumor necrosis factor on human hair follicles. Arch Dermatol. 2004 Aug;140(8):1012. doi: 10.1001/archderm.140.8.1012-a. No abstract available.'}, {'pmid': '15928633', 'type': 'BACKGROUND', 'citation': 'Strober BE, Siu K, Alexis AF, Kim G, Washenik K, Sinha A, Shupack JL. Etanercept does not effectively treat moderate to severe alopecia areata: an open-label study. J Am Acad Dermatol. 2005 Jun;52(6):1082-4. doi: 10.1016/j.jaad.2005.03.039.'}, {'pmid': '18280336', 'type': 'BACKGROUND', 'citation': 'Price VH, Hordinsky MK, Olsen EA, Roberts JL, Siegfried EC, Rafal ES, Korman NJ, Altrabulsi B, Leung HM, Garovoy MR, Caro I, Whiting DA. Subcutaneous efalizumab is not effective in the treatment of alopecia areata. J Am Acad Dermatol. 2008 Mar;58(3):395-402. doi: 10.1016/j.jaad.2007.10.645.'}, {'pmid': '18216487', 'type': 'BACKGROUND', 'citation': 'Fabre C, Dereure O. Worsening alopecia areata and de novo occurrence of multiple halo nevi in a patient receiving infliximab. Dermatology. 2008;216(2):185-6. doi: 10.1159/000111523. Epub 2008 Jan 23. No abstract available.'}, {'pmid': '16686916', 'type': 'BACKGROUND', 'citation': 'Cutrer FM, Pittelkow MR. Cephalalgic alopecia areata: a syndrome of neuralgiform head pain and hair loss responsive to botulinum A toxin injection. Cephalalgia. 2006 Jun;26(6):747-51. doi: 10.1111/j.1468-2982.2006.01098.x. No abstract available.'}, {'pmid': '7518880', 'type': 'BACKGROUND', 'citation': 'Paus R, Heinzelmann T, Schultz KD, Furkert J, Fechner K, Czarnetzki BM. Hair growth induction by substance P. Lab Invest. 1994 Jul;71(1):134-40.'}, {'pmid': '10025752', 'type': 'BACKGROUND', 'citation': 'Olsen E, Hordinsky M, McDonald-Hull S, Price V, Roberts J, Shapiro J, Stenn K. Alopecia areata investigational assessment guidelines. National Alopecia Areata Foundation. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):242-6. doi: 10.1016/s0190-9622(99)70195-7. No abstract available.'}, {'pmid': '15545544', 'type': 'BACKGROUND', 'citation': 'Hsu TS, Dover JS, Arndt KA. Effect of volume and concentration on the diffusion of botulinum exotoxin A. Arch Dermatol. 2004 Nov;140(11):1351-4. doi: 10.1001/archderm.140.11.1351.'}]}, 'descriptionModule': {'briefSummary': "Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is still unclear, however, it is believed to be an autoimmune disease. This disease is not a life-threatening condition but it has a significant psychological impact to patient's quality of life.\n\nMany triggers have been proposed such as viral infection, stress and neurologic factors. There are many studies show the correlation between disease activities and neurotransmitters level. Substance P and calcitonin gene-related peptide play major role in early stage of disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss of immune privilege of hair follicles.\n\nThe conventional treatment of alopecia areata with intralesional corticosteroid injection might treat the end of pathogenesis process.\n\nThere is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates inhibition release of substance P in many publications.\n\nTo sum up, the treatment of alopecia areata with intralesional corticosteroid injection still be a standard treatment, nevertheless, patients have to receive this treatment every month until regrowth of scalp hair. Corticosteroid injection have several side effects, for example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression. Moreover, injection pain is also affect to psychological aspect .\n\nThis study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and reduce corticosteroid side effects, as well as, others opportunity cost. There is no prospective, randomized-controlled trial of comparison study between botulinum toxin A injection and corticosteroid injection for alopecia areata, therefore, investigators conduct this study for the greatest benefit to alopecia areata patients and for the future research in disease etiology.", 'detailedDescription': "Inclusion criteria\n\n1. Patients must be above 18 years old\n2. Newly diagnosed with multiple alopecia areata\n3. Patient has lesions on the both side of the scalp.\n4. Lesions's diameter varies between 2-6 cms\n\nExclusion criteria\n\n1. Having active scalp inflammation\n2. Allergic to botulinum toxin A or human albumin\n3. Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications\n4. Diagnosed with neuromuscular diseases such as Myasthenia gravis\n5. Pregnant, breast feeding, plan to pregnant patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Patients must be above 18 years old\n* Newly diagnosed with multiple alopecia areata\n* Patient has lesions on the both side of the scalp.\n* Lesions's diameter varies between 2-6 cms\n\nExclusion criteria\n\n* Having active scalp inflammation\n* Allergic to botulinum toxin A or human albumin\n* Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications\n* Diagnosed with neuromuscular diseases such as Myasthenia gravis\n* Pregnant, breast feeding, plan to pregnant patients"}, 'identificationModule': {'nctId': 'NCT00999869', 'briefTitle': 'The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata', 'orgStudyIdInfo': {'id': 'SirirajH-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin A', 'description': 'At first visit, patients will be randomized by blocked randomization into 2 sides of scalp. Experimental side will be injected with botulinum toxin A ( Botox) 2 units per 6.05 cm2 of lesion ( Concentration 2 units of Botox per 0.1 ml of normal saline ).', 'interventionNames': ['Drug: Botulinum toxin type A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide', 'description': 'At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side', 'interventionNames': ['Drug: Triamcinolone acetonide']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'otherNames': ['Botox( Allergan Inc.)'], 'description': 'Using concentration at 2 units per 0.1 of dilution with normal saline Injection in the first visit and follow up at 1 week, 1,2,3 and 4 months after injection', 'armGroupLabels': ['Botulinum toxin A']}, {'name': 'Triamcinolone acetonide', 'type': 'DRUG', 'otherNames': ['Kenacort'], 'description': 'Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution', 'armGroupLabels': ['Triamcinolone acetonide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rattapon Thuangtong, M.D.', 'role': 'CONTACT', 'email': 'rattaponthuangtong@yahoo.com'}], 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rattapon Thuangtong, MD.', 'role': 'CONTACT', 'email': 'rattaponthuangtong@yahoo.com', 'phone': '(66)-2-419-7000', 'phoneExt': '4332'}, {'name': 'Supenya Varathai, MD.', 'role': 'CONTACT', 'email': 'supenya_v@yahoo.com', 'phone': '(66)-2-419-7000', 'phoneExt': '4332'}, {'name': 'Suthasinee Pattaravadee, B.Sc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Rattapon Thuangtong, MD.', 'role': 'CONTACT', 'email': 'rattaponthuangtong@yahoo.com', 'phone': '(66)-2-419-7000', 'phoneExt': '4332'}, {'name': 'Supenya Varothia, MD.', 'role': 'CONTACT', 'email': 'supenya_v@yahoo.com', 'phone': '(66)-2-419-7000', 'phoneExt': '4332'}], 'overallOfficials': [{'name': 'Rattapon Thoungtong, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand'}, {'name': 'Supenya Varothai, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand'}, {'name': 'Rasthawathana Desomchoke, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand'}, {'name': 'Kumpol Aiempanakit, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistance professor', 'investigatorFullName': 'Rattapon Thuangtong', 'investigatorAffiliation': 'Siriraj Hospital'}}}}